Nelarabine Related Compounds & Impurities

Nelarabine is a deoxyguanosine analogue prodrug of ara-G used for relapsed/refractory T-cell acute lymphoblastic leukaemia.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Nelarabine reference standards, pharmacopeial and non-pharmacopeial Nelarabine impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Nelarabine-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Nelarabine
Nelarabine Regio Isomer
6-O-Methyl Guanosine
Nelerabine Impurity 16
(2R,3S,4S,5R)-2-(2-amino-8-hydroxy-6-methoxy-7H-purin-9(8H)-yl)-5-(hydroxymethyl)tetrahydrofuran-3,4-diol
Nelerabine Impurity 18
(E)-N-(2,4-diamino-6-methoxypyrimidine-5yl)formimidic acid
6-methoxy-2-nitro-9-(2,3,5-tri-O-acetyl-beta-D-arabinofuranosyl)-9H-purine
Nelarabine Alpha Isomer
Nelarabine Impurity 24
Nelarabine Impurity 25
Nelarabine Impurity 21
Nelarabine Impurity 1
Nelarabine Impurity 2